OSI Pharmaceuticals, Inc announced the initiation of two clinical trials with OSI-906, the company's potential first-in-class, oral insulin-like growth factor-1 receptor (IGF-1R) inhibitor. The first study is a phase-III, multi-center study that will evaluate the use of OSI-906 for patients with locally advanced or metastatic adrenocortical carcinoma (ACC). The study is designed to determine overall survival for patients receiving single-agent OSI-906 versus placebo and will also evaluate progression free-survival, disease control rate, overall response rate as well as safety. The second study is a phase-I/II trial evaluating OSI-906 in combination with the chemotherapy paclitaxel (Taxol), primarily in patients with recurrent epithelial ovarian cancer.

"Data from our phase-I programme for OSI-906 show encouraging evidence of anti-tumor activity, particularly in adrenocortical carcinoma. We are pleased to initiate a phase-III trial in this underserved patient population where the only approved therapy is Mitotane, a cytotoxic derivative of the pesticide DDT," said Colin Goddard, chief executive officer, OSI Pharmaceuticals.

OSI-906 is a potent inhibitor of IGF-1R which has been viewed as an important therapeutic target due to its involvement in the growth and proliferation of a variety of human cancers, including ACC, ovarian and non-small cell lung (NSCLC) cancers. IGF-1 and IGF-2 are growth factors, or hormones, know to stimulate growth and survival of cancerous cells. The likely tie-in of IGF-2 over-expression as a strong driver of tumour signalling in ACC - where it is over-expressed in approximately 90 per cent of patients - and also in ovarian cancer provided the rationale for the Company's decision to aggressively pursue these indications. In addition, OSI intends to initiate a registration-oriented combination study of OSI-906 with Tarceva (erlotinib) in NSCLC. Initial indications of monotherapy activity for OSI-906 in NSCLC and our translational research data suggesting that compensatory signaling mechanisms and epithelial-mesenchymal transition (EMT) phenomena may make a combination of Tarceva and OSI-906 synergistically effective in the NSCLC setting provide the rationale for this clinical trial which is intended to begin in 2010.

OSI Pharmaceuticals is committed to 'shaping medicine and changing lives' by discovering, developing and commercializing high-quality, novel and differentiated targeted medicines designed to extend life and improve the quality of life for patients with cancer and diabetes/obesity.